DTRAX® Spinal System DX-22-100
GUDID 10852776006086
The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Spinal endoscopic-access system| Primary Device ID | 10852776006086 |
| NIH Device Record Key | a0b1a72a-e599-4d5d-b787-195186a81dc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTRAX® Spinal System |
| Version Model Number | DX-22-100 |
| Catalog Number | DX-22-100 |
| Company DUNS | 969820245 |
| Company Name | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852776006089 [Primary] |
| GS1 | 10852776006086 [Package] Contains: 00852776006089 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180876
FDA Product Code
| HRX | Arthroscope |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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[10852776006086]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2017-06-27 |
Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.
| 00852776006478 - CORUS-LX Implant, 4mm | 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant. |
| 00852776006539 - CORUS-LX Implant, 5mm | 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant |
| 00852776006546 - CORUS-LX LevelOne, 4mm | 2025-08-21 Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelO |
| 00852776006577 - CAVUX Cage-LX, 5mm | 2025-07-16 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine |
| 00852776006645 - CORUS PCSS Implant 4mm | 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz |
| 00852776006676 - CORUS PCSS Implant, 5mm | 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz |
| 00852776006683 - CORUS PCSS LevelOne, 4mm | 2025-02-27 Three related devices: CORUS PCSS Implant, CORUS Spinal System and DiViNE Portal System, referred to as “CORUS™ PCSS LevelO |
| 00852776006447 - CAVUX CERVICAL CAGE-X, 5MM | 2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac |
Trademark Results [DTRAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DTRAX 87939439 not registered Live/Pending |
Deloitte LLP 2018-05-29 |
 DTRAX 87375466 5322967 Live/Registered |
Providence Medical Technology, Inc. 2017-03-17 |
 DTRAX 85115258 4176247 Live/Registered |
Providence Medical Technology, Inc. 2010-08-25 |
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